Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
John Byrd
Study ID
NCT00201682
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etanercept — DRUG
    25 mg SQ twice weekly weeks 1-5
  • Rituximab — DRUG
    (375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5

Study Details

This is a phase I/II study of the combination of etanercept and rituximab in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination is proposed to improve the efficacy and diminish the toxicity of this the

Key Dates

Start date
Oct 31, 2002
Status verified
Feb 2017
Primary completion
Aug 31, 2006
Completion
Aug 31, 2009

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Etanercept 25 mg administered sub-cutaneously twice weekly (Monday and Thursday) weeks 1-5 of therapy (total of 10 doses). The third dose of etanercept will be administered 1 hour prior to receiving rituximab. Rituximab: Patients will receive 375 mg/M2 of rituximab three times weekly for four weeks (a total of 12 doses of rituximab).

Primary Outcome Measure

To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL. [ Time Frame: up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Ohio State University Medical Center· Columbus, OH

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